Company
pharmaceuticals
SeniorRegulatoryAffairsManager
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Regulatory Affairs Manager. Skills: regulatory affairs, project management. Set up regulatory strategy, product registration timeline and ensure well implement.. Prepare and validate registration dossier for CTA, NDA, Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines.”
What You'll Achieve.
ensure well implement; ensure timely approval; fully meet Chinese regulations and guildlines; achieve registration approvals on schedule; ensure clear registration status; support regulatory submissions and approvals in the most efficient; keep the effective registrations; ensure no delay for the market supply due to IDL renewal; guarantee effective product registrations; share with cross-functions timely; promote the best performance of team work; complete urgent assignments as required in a timely manner
Industry & Context.
Effective problem solving; handle technical issues from regulatory authorities
What They're Looking For.
Must Have
Over 5 years working experience in regulatory affairs for pharmaceuticals, more than 3 years in the project management, Solid registration project management, Effective problem solving and planning, Good knowledge of CFDA regulations, Good working relationship with regulatory, Good command of oral and written, Good communication and management skill
What You'll Do.
Set up regulatory strategy
product registration timeline and ensure well implement.
Prepare and validate registration dossier for CTA
Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines.
Responsible for CTA applications
variation applications (such as CMC changes
specification upgrades etc. )
including establish the filing strategy
source documents collection and application dossiers preparation
filing and following communications
follow the regulatory progress.
Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule.
Develop and maintain tracking system for registration procedure to ensure clear registration status.
Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.
Provide regulatory support to Medical and Marketing team as well as other company personnel.
Review promotion materials according to the internal SOP.
Communicate with area RA & local functions to keep the effective registrations
and ensure no delay for the market supply due to IDL renewal.
Establish and maintain good working relationships with regulatory authorities (CFDA
institute for drug control
and so on) to guarantee effective product registrations.
Follow up policy change related to business in terms of RA and share with cross-functions timely.
Train and develop subordinates
provide good supports
well coordinate with colleagues
and create positive working environment to promote the best performance of team work.
Establish internal SOP and WI.
Assist supervisor to complete urgent assignments as required in a timely manner.
How You'll Work.
Team & Collaboration
Provide regulatory support to Medical and Marketing team as well as other company personnel.; Communicate with area RA & local functions to keep the effective registrations, and ensure no delay for the market supply due to IDL renewal.; Establish and maintain good working relationships with regulatory authorities (CFDA, CDE, institute for drug control, and so on) to guarantee effective product registrations.; Train and develop subordinates, provide good supports, well coordinate with colleagues, and create positive working environment to promote the best performance of team work.; share with cross-functions timely.
Communication Scope
Good command of oral and written; Good communication and management skill
Process & Methodology
Solid registration project management, product registration timeline, Track on-going projects, Develop and maintain tracking system for registration procedure, Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.
Full Job Description
## **JOB DESCRIPTION:** EXPERIENCE: * Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post; * Solid registration project management skills; * Effective problem solving and planning capabilities; * Good knowledge of CFDA regulations and guidelines; * Good working relationship with regulatory authorities; * Good command of oral and written English; * Good communication and management skill. RESPONSIBILITIES: * Set up regulatory strategy, product registration timeline and ensure well implement. * Prepare and validate registration dossier for CTA, NDA, Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines. * Responsible for CTA applications, line extension, license renewal, variation applications (such as CMC changes, safety updates, local repackaging, specification upgrades etc.), including establish the filing strategy, source documents collection and application dossiers preparation, filing and following communications, follow the regulatory progress. * Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule. * Develop and maintain tracking system for registration procedure to ensure clear registration status. * Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient. * Provide regulatory support to Medical and Marketing team as well as other company personnel. * Review promotion materials according to the internal SOP. * Communicate with area RA & local functions to keep the effective registrations, and ensure no delay for the market supply due to IDL renewal. * Establish and maintain good working relationships with regulatory authorities (CFDA, CDE, institute for drug control, and so on) to guarantee effective product registrations. * Follow up policy change related to business in terms of RA and share with cr
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